JP3340749B2 - In particular, a connection device between a container and a syringe provided with a stopper member that can be pierced. - Google Patents

Abstract

PCT No. PCT/FR97/01676 Sec. 371 Date Feb. 9, 1999 Sec. 102(e) Date Feb. 9, 1999 PCT Filed Sep. 24, 1997 PCT Pub. No. WO98/13006 PCT Pub. Date Apr. 2, 1998A connecting device (1) between a first receptacle (2) and a second receptacle (4) comprising a muff joint (4a), the device comprising an apparatus (5) for perforating a stopper, including a faucet (6) and a filtering chamber (7) isolated from outside by a filter (8), two independent channels (9, 10) being provided in the perforating apparatus (5) for communicating the inside of the first receptacle (2) with the faucet (6) and the filtering chamber (7) respectively, the device further comprising an element (11) for displacing with guidance the perforating apparatus (5), an element for fastening (13) the skirt (12) on the neck (2a), a plunger (15) mounted in the internal bore (12a) on which the perforating apparatus (5) are fixed, for sliding by simple pressure, and an element (16) for definitively stopping the plunger (15).

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

[Industrial applications]

The present invention generally relates to a connection technique between a first container having a neck portion sealed by a viscoelastic stopper member capable of being penetrated and a second container having a muff joint (convex side member).

The present invention comprises, on the one hand, a first container which is constituted, for example, by a rigid flask made of glass, the neck of which is sealed by a rubber stopper member which can be pierced, and A rigid container constituted by a syringe and usually connected to a muff joint, for example, a rigid tubular body of a luer lock type, and a plan sliding hermetically inside the tubular body. A more detailed and objective introduction, definition and explanation of the connection technology between the second container equipped with the jar. The above connection technique mixes a pharmaceutical solution or suspension from a powdered or freeze-dried active ingredient in a first container, ie, a flask, and a solvent (eg, a liquid) in a second container, ie, a syringe. It is especially needed in some cases. In such a case, the following operation is generally performed.

[0003] A first container (flask) is provided, and a second container (syringe) is filled with a solvent. Then, in order to connect the two containers, a hole is formed in the stopper member by a suitable through-hole means (provided on the syringe or separately prepared). The solvent in the second container (syringe) is introduced into the first container (flask) from a syringe disposed on the flask in order to mix the solvent and the powdery or freeze-dried active ingredient. When a solution or suspension is made in the first container (flask), the assembly members provided with the flask and the syringe and connected to each other by the through-hole means are turned upside down, and the first container is placed on the second container. Is arranged. When the plunger of the syringe is pulled, the solution or suspension of the active ingredient is withdrawn from the first container and introduced into the second container. With the syringe needle placed on the muff joint of the syringe, the preparation of the syringe containing the solution or suspension of the active ingredient is completed.

A transfer device with a piercable stopper member for connecting two containers as defined and exemplified above has already been disclosed in the publication EP-A-0 126 718. The transfer device, on the one hand, is, for example, a luer lock for a firm connection to the muff joint of the second container.
A plug member (concave member) for obtaining a strong connection, such as a conical member of the "ock" type, and, on the other hand, a filter (eg, any gaseous or liquid material passing in one direction or the other). To connect the inside of the first container, the plug member and each of the filtration chambers at a position where the stopper member is pierced by the through-hole means and the filtration chamber which is isolated from the outside by the absolute filter which can sterilize even the flow of water. And two independent connecting paths provided in the through-hole means.

[0005] The connecting device further includes at least a skirt portion forming an internal hole, and a means for guiding a through-hole means, and is moved to a fixed position above the stopper member where the internal hole is formed. Means for fixing to the neck portion of the first container, means for sealing the internal hole to the outside at the fixing position of the skirt portion, and the through-hole end from a position before operation in which the through-hole end is separated from the stopper member. Has a plunger fixed or provided with through-hole means to slide with a single pressure to a position through the stopper member.

[0006] Such a connection device is a connected device or a connected device.
Since the relative operation of the two containers is not controlled, the solvent introduced into the first container and consequently withdrawn, for example, by the relative operation of the plunger and the tubular body of the syringe (second container) Or it is difficult to accurately determine the amount of liquid.

The present invention aims at minimizing and keeping in particular the dead volume (ie the amount of liquid that cannot be drawn from the first container by connecting the two containers) with the first container and the When two containers are connected, the relative operation of the containers is better controlled.

[0008] The connection device according to the present invention further includes a means for definitely stopping the plunger at the penetrating position. And
The stopping means comprises a fastening member arranged on the upper or side of the plunger and an auxiliary stopping member arranged on the upper or side of the skirt, and the fastening member is distributed around the axis of the plunger. And a plurality of teeth having elasticity in a distal direction or a central direction, and the auxiliary stop member has a circumferential side surface for blocking the teeth.

BRIEF DESCRIPTION OF THE DRAWINGS [0009] The invention can be referred to the following drawings, in which: FIG. 1 is a longitudinal sectional view of a connection device according to the present invention, which is fixed and locked to a first container, and shows a state before a plunger including a through-hole means is operated. In this figure, the connection device is provided with a cap member for keeping the inside sealed from the outside.

FIG. 2 shows a state where the cap member of FIG. 1 is removed, and the second container is attached to the through-hole means before operation. FIG. 3 shows a state in which the plunger and the through-hole means are operated or pierced from the state shown in FIG. 2, and the liquid in the second container is introduced into the first container (in the present embodiment, the second container is constituted). (Depressing the plunger of the syringe). FIG. 4 shows a state where the assembly member obtained by assembling the two containers connected from the state shown in FIG. 3 is turned upside down. In this state, for example, when the plunger of the syringe is pulled, the liquid in the first container becomes the second liquid. Introduced into two containers.

As shown in FIGS. 1 and 2, on the one hand, the connecting device described below has a neck part closed by a stopper member 3 made of a viscoelastic material (rubber) having an annular bead 2b and capable of penetrating therethrough.
2a and a first container 2 comprising, for example, a glass flask with a shoulder 3b mounted horizontally on the annular bead 2b.
(The flask contains the active ingredient as a premise and in use, especially in a sealed and sterilized state against external liquids, for example in powdered or freeze-dried form) Tubular body 4b with muff joint 4a
A conventional syringe having a luer lock type conical member attached to one end of the tubular body 4b, and a plunger 21 capable of filling and emptying the syringe. In particular, the second container can be firmly connected to the outside so as to maintain a preset sterilization state.

According to the invention, the connection device, which can penetrate the stopper member 3 and connect the two containers exemplified above, generally comprises means 5 for penetrating the stopper member and at least the skirt 12 And means 11 for guiding said means for perforation, constituted by a plunger 15 to which said means for perforation 5 are added (or provided), means 13 for fixing the skirt 12 to the neck 2a of the first container. Means for sealing the inside of the skirt portion 12 using the viscoelasticity of the upper portion of the stopper member 3
14 and means 16 for fixedly stopping the plunger 15 in the through hole or in the through hole state as shown in FIGS. 3 and 4 and fixing the plunger 15 to the side of the second container (2). I have.

As shown in FIG. 1, the through-hole means 5 includes a shaft 5b having a through-hole end 5a at an end thereof, and a collar for fixing the through-hole means 5 to a plunger 15 (described later). 5c, a peripheral opening 5d, and a plug member 6 extending from the shaft portion 5b and firmly connected to the muff joint (concave member) 4a of the second container (syringe).
It is composed of At the opposite side of the through-hole end 5a, which is equivalent to the through-hole means 5 and is formed between the inclined shoulder of the plunger 15 and the filter 8, the corresponding shoulder of the collar 5c and the plunger 15 is formed. , And a filtration chamber 7 isolated from the outside is formed. The plug member 6 disposed at the opposite side of the through-hole end 5a has a filter 20 capable of filtering any liquid passing in one direction or the other. For example, as shown in FIGS. 2 to 4, in the through-hole state where the through-hole means 5 completely penetrates the stopper member 4 by the through-hole end 5a, the shaft portion 5b of the through-hole means 5 has Two independent connecting paths 9 and 10 are formed to connect the inside of the container 2, the plug member 6 and the filtration chamber 7, respectively.

The means 11 for guiding the through-hole means 5 includes a tubular skirt portion 12 forming an inner hole 12a, and a plunger 15 mounted on the inner hole 12a (where the through-hole means 5 is fixed or mounted). ). Skirt part 12
Is made of plastic, for example, as an integral body with a fixing means 13 and projects beyond the free end of the plug member 6 to prevent inadvertent operation by the user's finger as shown in FIG. ing. The skirt portion 12 further includes a first container 2
There is provided a fixing means 13 which is fixed below the annular rim 2b, abuts against the neck 2a, and can urge the lower end in the circumferential direction toward the center by elasticity in the radial direction. Actually, the fixing means 13 is formed with a plurality of fixing teeth, and is configured to generate an elastic force in the radial direction as described above. In the fixed state shown in FIGS. 1 to 4, an internal hole 12 a is formed on the stopper member 3, particularly in an upper portion of the through-hole means 5 which can access the through-hole end 5 a. The means 14 for sealing the internal hole 12a from the outside by using the viscoelasticity of the stopper member 3 is similarly formed as an integral part of the skirt portion 12. These means consist, in particular, of continuous, relatively hard, circumferential ribs which at least partially penetrate the relatively soft material part of the stopper member 3.

The plunger 15 is constituted by a transverse core portion 15a having a shoulder hole 15b through which the shaft portion 5b of the through hole means 5 can be inserted while supporting the through hole means 5 in the axial direction. As described above, the airtightness of the through-hole means 5 is maintained by the collar 5c at the shoulder near the inclined surface of the filtration chamber 7. Means 19 below
The rotation of the plunger 15 added to the inner hole 12a is prevented by the rotation of the plunger 15 by the simple axial pressure, so that the through-hole end 5a is separated from the stopper member 3 before the operation (FIGS. 1 and 2). 2), the through hole end 5a completely penetrates the stopper member 3 (FIGS. 3 and 4).
). Means 19 for preventing rotation of the plunger 15 with respect to the skirt portion 12 include eight grooves provided on the inner surface of the skirt member 12 and parallel to the axis of the device disposed on the periphery of the skirt portion. And eight engaging ribs (not shown) provided on the plunger side and capable of engaging with the grooves.

The plunger 15, that is, the means 16 for definitely stopping the through-hole means 5 at the penetrating position where the through-hole end of the through-hole means 5 completely passes through the stopper member 3 has the following configuration. That is, one or a plurality of fastening members 17 provided on the plunger 15 and arranged around the axis of the plunger 15 and formed of teeth having elasticity in the centrifugal direction or the center direction (this fastening member 17 is , Internal hole
A concentric circle is formed with respect to the axis of the plunger 15 in a skirt portion 15c for securely sliding the plunger in 12a), and the skirt portion 12 is provided with, for example, an annular piece. It comprises one or more auxiliary stop members 18 that block the teeth when moving toward the stopper member 3.

At a position facing the stopper member 3, the cap member 21 has a skirt portion for accommodating the plug member 6 and other internal members of the device, ie, the plunger 15 and the through-hole means 5, in a state of being isolated from the outside. The inner member 12 is closed so as to hermetically close and is firmly fixed to the skirt portion 12. Such a sealed state is achieved particularly by the peripheral plate 19a provided on the outer surface of the skirt portion 12 and having the cap member 21 blocked at the upper portion. The term "sealing" means at least sealing with respect to a liquid, and particularly has a meaning that a sterilized state inside the connection device can be maintained.

Furthermore, the connection device according to the present invention is ultimately
Fixed to Finally, the means 22 for finally locking the connection device to the first container 2 blocks the fixing means 13 in a positional relationship fixed to the neck 2a of the first container 2, and the main connection is completed. This locking means is located in particular on the outer ring of the device, is integrally formed with a cap member 21 and is a line (a line of weak
ening) is divided from there by 30.

The function of the connection device 1 according to the present invention can be understood from the description of FIGS. 2 to 4 with reference to the description of the present specification and each drawing.

The devices described above have yet another important advantage. In particular, the device 16 is used only once, since the means 16 for deterministically stopping the plunger 15 is not allowed to be reused. In particular, regarding the arrangement and movement of the plunger 15,
This device is completely safe to use because there is no intervening matter other than being pushed by the muff joint of the syringe, and the user does not touch the through-hole end 5a of the through-hole means 5 with a finger. In addition, the user does not need to touch the plunger 15 and / or the through-hole means 5 with his / her finger, and the user is not injured.

────────────────────────────────────────────────── ─── Continuation of the front page (56) References JP-A-6-90993 (JP, A) JP-A-1-135354 (JP, A) JP-A-50-144576 (JP, A) JP-A-60-1985 222059 (JP, A) JP-A-56-59036 (JP, U) US Patent 5,666,660 (US, A) European Patent Application Publication 126718 (EP, A1) (58) Fields investigated (Int. Cl. ⁷ , DB) Name) A61J 1/20

Claims (7)

(57) [Claims] 1. A first container (2) having a pierceable viscoelastic stopper member (3) for sealing a neck portion (2a);
A connection device (1) for connecting a second container (4) having a muff joint (convex side member) (4a), wherein a through-hole means (5) for passing through a stopper member (3); A plug member (concave member) (6) for firmly connecting the hole means (5) to the muff joint (4a), and filtration for isolating the through-hole means (5) from the outside via a filter (8). Chamber (7) and two independent connections for connecting the interior of the first container (2) with each of the plug member (6) and the filtration chamber (7) at the perforated position of the perforating means (5). (9,10)
Means for guiding the through-hole means (5) to the position of the through-hole (11)
And a skirt (12) having an internal hole (12a), and a skirt (1) abutting on a neck (2a) of the first container (2).
A fixing means (13) for fixing the inner hole (2), a means (14) for sealing the internal hole (12a) from the outside, and a through-hole means (5) are fixed. A plunger (15) that slides with a simple pressure from a position before the through hole (FIGS. 1 and 2) in which the hole end (5a) is away from the stopper member (3) to a through hole position (FIGS. 3 and 4); And one or more fastening members (17) distributed around the axis of the plunger (15) and having elasticity in the centrifugal direction or the center direction; and the fastening member (17) provided on the skirt portion (12). (16) using one or more auxiliary stop members (18) to block the plunger (15) at the through-hole position. The first container (2) is stopped and fixed to the side of the first container (2). When the connection is released, the connection device, characterized in that it is configured so as to remain fixed to the side of the plunger (15) a first container (2). 2. The connection device according to claim 1, wherein a rotation of the plunger (15) with respect to the skirt (12) is prevented between the plunger (15) and the skirt (12). Connection device characterized by comprising means (19). 3. The connecting device according to claim 1, wherein the second container (4) is a syringe, and the plug member (6) is a luer lock type conical member (4a). Connection equipment characterized by the above. 4. The connection device according to claim 1, wherein the filter has a porosity for sterilizing and filtering all gaseous or liquid flows passing therethrough. 5. The connecting device according to claim 1, further comprising a cap member (21) for sealing a skirt (12) facing the stopper member (3). 6. The connecting device according to claim 1, further comprising means (22) for finally locking the connecting device itself to the first container (2) by blocking the fixing means (13). Connecting equipment characterized by the following. 7. The connecting device according to claim 1, wherein the plug member (6) is a filter (20) for filtering a passing liquid.
A connection device, comprising: